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A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice

This study is currently Recruiting

May 2011 By Apatech, Inc.

First Recieved on September 8, 2009

Last Updated on May 20, 2011

Sponsor: Apatech, Inc.
Collaborators:
Information provided by: Apatech, Inc.
Identifier: NCT00974623

Purpose

A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.

Study Type: Observational
Study Design: Observational Model: Cohort, Time Perspective: Prospective

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: - The patient has failed conservative treatment and is a candidate for spinal fusion surgery. - The patient is ?18 years old and of legal age of consent. - The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent. - The patient is skeletally mature (epiphyses closed). - The patient has signed the IRB approved informed consent. - The patient is willing and able to participate in post-operative clinical and radiographic follow up evaluations for 2 years. Exclusion Criteria: - Patient has systemic infection or infection at the surgical site. - Patient has a medical condition that would interfere with post-operative assessments and care (i.e., neuromuscular disease, psychiatric disease, paraplegia, quadriplegia, etc.). - Patient is in poor general health or any concurrent disease process that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease). - Patient has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the patient's ability to complete the protocol required follow-up. - The patient is pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the study. - Patient is participating in another investigational study, which could confound results.

Investigators

  • Investigator: Melanie Marshall - Study Director - VP of Clinical Operations

Locations

  • UCSF

    San Francisco, California 94143 United States

  • St. Joseph's Hospital - Resurgeons Orthopedics

    Atlanta, Georgia 30342 United States

  • Arthritis & Joint Center - U. Mass. Memorial

    Worcester, Massachusetts 01605 United States

  • PRESSD

    Southfield, Michigan 48072 United States

  • Montana Neuroscience Institute Foundation

    Missoula, Montana 59802 United States

  • Syracuse Orthopedic Specialists

    Syracuse, New York 13215 United States

  • Neurosurgical Associates

    Nashville, Tennessee 37203 United States

  • Brain & Spine of Texas

    Plano, Texas 75093 United States

Conditions related to this trial:

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